International ISO Standard IS08637-3 Second edition Extracorporeal systems for blood 2024-05 purification - Part 3: Plasmafilters Systemes extracorporels pour la purification du sang - Partie 3: Filtres pour plasma Reference number IS0 8637-3:2024(en) @ ISO 2024 @IS02024 be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IsO at the address below or ISO's member body in the country of the requester. ISO copyright office CP 40i : Ch. de Blandonnet 8 CH-1214Vernier,Geneva Phone: +41 22 749 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland @ IS0 2024- All rights reserved i Contents Page Foreword. ..iv .. Introduction Scope. 1 .1 2 Normative references .1 3 Terms and definitions. .2 .3 4 Requirements ..3 4.1 Biological safety and haemocompatibility 4.2 Sterility .3 3 4.3 Non-pyrogenicity 4.4 Mechanical characteristics. .3 4.4.1 ..3 Structural integrity. Blood compartment integrity 4.4.2 .3 .4 4.4.3 Connectors 4.5 Performance characteristics. ..5 Plasma filtration rate 4.5.1 ..5 4.5.2 Sieving coefficient ..6 4.5.3 Blood compartment volume 4.5.4 Blood compartment pressure drop ..6 Haemolytic characteristics 4.5.5 .6 4.6 Expiry date. ..6 5 Test methods. .6 5.1 General .6 5.2 Biological safety and haemocompatibility .7 5.3 Sterility 5.4 Non-pyrogenicity .7 5.5 1 Mechanical characteristics. 5.5.1 Structural integrity. .7 .7 5.5.2 Blood compartment integrity 5.5.3 Connectors ..8 5.6 Performance characteristics. .11 5.6.1 .11 Test solution 5.6.2 Plasma filtration rate Test procedure .11 5.6.3 Sieving coefficient. .11 5.6.4 Blood compartment volume. 13 Blood compartment pressure drop 5.6.5 13 5.6.6 Haemolytic characteristics. .13 5.7 Expiry date ..14 Labelling .14 6 Labelling on the device. .14 6.1 6.2 Labelling on unit containers. 15 6.3 Labelling on the outer containers ..15 6.4 Information to be given in the accompanying documentation .16 Packaging .17 7 Bibliography .18 @ IS0 2024 - All rights reserved iii